QA Manager- Clinical Trials

Job Overview:

Labcorp Drug Development is seeking candidates for a QA Manager. The QA Manager will be remotely located (home-based) anywhere within the United States.

  • Ensure the consistent implementation, use and review of SOPs.
  • Escalate issues to management in a timely manner implementing appropriate solutions, including preventative actions.
  • Negotiate with functional and operational internal stakeholders to improve quality and increase efficiencies.
  • Analyze and interpret data in order to lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes.
  • Lead and effectively manage constructive crucial interactions with clients or regulatory agencies.
  • Lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes.
  • Interpret applicable quality regulations/standards and create appropriate policies and procedures.
  • Ensure Regulatory Compliance and Quality Assurance (RC&QA) management responsibilities, as indicated in applicable controlled documents, are followed.
  • Perform other duties, as assigned by management.
  • Travel essential to Labcorp Drug Development by Labcorp offices primarily located in Princeton, NJ and Druham, NC with respect to adhering to pandemic restrictions.


Education/Qualifications:

  • A minimum of a Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience).
  • Experience may be substituted for education.


Experience:

  • 8 years in a GCP regulatory environment.
  • Experience & regulatory expertise of industry quality systems/standards.
  • Experience with hosting internal, external and FDA audits.
  • Ability to interpret applicable regulations/standards.
  • Experience in leading process improvement initiatives.
  • Ability to communicate and negotiate internal stakeholders effectively.


Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status. For more information about how we collect and store your personal data, please see our Privacy Statement



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